search
Back to results

The Effect of Dual Attention in an EMDR Intervention (DA_EMDR)

Primary Purpose

Trauma, Psychological, Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
A comprehensive third-generation intervention EMDR + dual attention
A comprehensive third-generation intervention EMDR + fixed point
A comprehensive third-generation intervention EMDR + exposition
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma, Psychological focused on measuring Trauma, Traumatic Stress Disorder, EMDR, Dual Attention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Those showing a high risk of PTSD (TSQ ≥6 or TSQ ≥4 with clinical criteria) will be further evaluated to determine whether they meet the inclusion criteria. Participants must: Be between the ages of 18 and 65 fluent enough in Spanish language; 2. Exclusion Criteria: Present severe active suicidal ideation, or have made a self-injurious attempt during the last month. Present a diagnosis of substance dependence, intellectual disability or severe cognitive dysfunction. Participants with a score greater than or equal to 26 on the BDI-II, the inclusion of the person in the study will be assessed by clinical criteria. Having received EMDR treatment in the last 6 months. Also excluded from the program are those people who cannot guarantee continuity in the therapeutic process.

Sites / Locations

  • Carmen ValienteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

EMDR+dual attention

EMDR + fixed point

EMDR + exposition

Arm Description

.Processing the trauma with exposition and dual attention.

Processing the trauma with exposition and fixed point.

Processing the trauma with exposition.

Outcomes

Primary Outcome Measures

Change from posttraumatic symptoms at 10 weeks and 6 months
International Trauma Questionnaire (ITQ; Cloitre et al., 2018). Higher scores mean a worse outcome.
Change from psychopathological symptoms at 10 weeks and 6 months
Symptom Checklist 45-SCL-90R brief (Davison et al., 1997).Higher scores mean a worse outcome.
Change from Dissociative symptoms at 10 weeks and 6 months
Dissociative Experience Scale DES II (Carlson and Putnam, 1993). Higher scores mean a worse outcome.

Secondary Outcome Measures

Change from Well-being at 10 weeks and 6 months
Scales of Psychological Well-Being (SPWB; Ryff & Keyes, 1995). Higher scores mean a better outcome.
Change from Satisfaction with life at 10 weeks and 6 months
Satisfaction with Life Scale (SWLS; Diener et al., 1985).Higher scores mean a better outcome.
Change from Emotion Regulation at 10 weeks and 6 months
Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski & Kraaij, 2007).Higher scores mean better outcome for functional dimensions and worse outcome for disfunctional dimensions
Change from Attachment style at 10 weeks and 6 months
Psychosis Attachment Measure (PAM; Berry, 2006). Higher scores mean a worse outcome.

Full Information

First Posted
October 26, 2022
Last Updated
November 10, 2022
Sponsor
Universidad Complutense de Madrid
search

1. Study Identification

Unique Protocol Identification Number
NCT05600868
Brief Title
The Effect of Dual Attention in an EMDR Intervention
Acronym
DA_EMDR
Official Title
The Effect of Dual Attention in an EMDR Intervention for Posttraumatic Symptomatology: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when higher-risk comorbidities (e.g., psychosis or substance use) are present. In particular, there are data pointing to the efficacy of prolonged exposure therapy and eye movement desensitization and reprocessing (EMDR) therapy. Clinical practice guidelines specifically recommend trauma-focused treatment with exposure and/or cognitive restructuring components. Regarding EMDR interventions, there are increasing results supporting its efficacy. Some interesting clinical advantages presented by EMDR as opposed to cognitive-behavioral therapies are 1) the efficacy found despite less exposure to the traumatic memory, 2) the exclusion of homework, 3) as well as the rapid reduction in subjective disturbance produced even after a single session of EMDR therapy. However, the mechanisms producing the improvement and, in particular, the effect of bilateral stimulation are not precisely known. More research is needed in this regard since bilateral stimulation is the most controversial part and with less evidence found. In addition to this, there are very few studies that have analyzed the differential efficacy of the presence or absence of bilateral stimulation or of the different types of stimulation possible. As for the comparison between types of stimulation (bilateral with eye movements, or focusing on a fixed point), greater treatment effects have been found for EMDR with fixation on an immobile hand compared to eye movements. The aim of this study is to examine the effectiveness of a comprehensive intervention protocol for people who have experienced traumatic events and present post-traumatic symptomatology. In addition, this study will compare the efficacy of traumatic memory processing with and without dual attention.
Detailed Description
The protocol will be developed following the three stages of recovery from trauma: first, focusing on establishing the therapeutic alliance and safety; second, focusing on recounting and re-processing the traumatic event; and third, focusing on reconnecting with others and with life despite the trauma experienced. This study will analyze the differences of type of traumatic processing; 1. using bilateral stimulation, 2. using fixed-point focusing and 3. closing the eyes (only exposure to the traumatic memory, without dual attention).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological, Traumatic Stress Disorder
Keywords
Trauma, Traumatic Stress Disorder, EMDR, Dual Attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMDR+dual attention
Arm Type
Active Comparator
Arm Description
.Processing the trauma with exposition and dual attention.
Arm Title
EMDR + fixed point
Arm Type
Active Comparator
Arm Description
Processing the trauma with exposition and fixed point.
Arm Title
EMDR + exposition
Arm Type
Active Comparator
Arm Description
Processing the trauma with exposition.
Intervention Type
Behavioral
Intervention Name(s)
A comprehensive third-generation intervention EMDR + dual attention
Intervention Description
This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with double attention.
Intervention Type
Behavioral
Intervention Name(s)
A comprehensive third-generation intervention EMDR + fixed point
Intervention Description
This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with fixed point.
Intervention Type
Behavioral
Intervention Name(s)
A comprehensive third-generation intervention EMDR + exposition
Intervention Description
This is a individual intervention with a total of 10 sessions. In the processing the traumatic event phase will be realized with exposition.
Primary Outcome Measure Information:
Title
Change from posttraumatic symptoms at 10 weeks and 6 months
Description
International Trauma Questionnaire (ITQ; Cloitre et al., 2018). Higher scores mean a worse outcome.
Time Frame
Change baseline, 10 weeks, and 6 months
Title
Change from psychopathological symptoms at 10 weeks and 6 months
Description
Symptom Checklist 45-SCL-90R brief (Davison et al., 1997).Higher scores mean a worse outcome.
Time Frame
Change baseline, 10 weeks, and 6 months
Title
Change from Dissociative symptoms at 10 weeks and 6 months
Description
Dissociative Experience Scale DES II (Carlson and Putnam, 1993). Higher scores mean a worse outcome.
Time Frame
Change baseline, 10 weeks, and 6 months
Secondary Outcome Measure Information:
Title
Change from Well-being at 10 weeks and 6 months
Description
Scales of Psychological Well-Being (SPWB; Ryff & Keyes, 1995). Higher scores mean a better outcome.
Time Frame
Change baseline, 10 weeks, and 6 months
Title
Change from Satisfaction with life at 10 weeks and 6 months
Description
Satisfaction with Life Scale (SWLS; Diener et al., 1985).Higher scores mean a better outcome.
Time Frame
Change baseline, 10 weeks, and 6 months
Title
Change from Emotion Regulation at 10 weeks and 6 months
Description
Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski & Kraaij, 2007).Higher scores mean better outcome for functional dimensions and worse outcome for disfunctional dimensions
Time Frame
Change baseline, 10 weeks, and 6 months
Title
Change from Attachment style at 10 weeks and 6 months
Description
Psychosis Attachment Measure (PAM; Berry, 2006). Higher scores mean a worse outcome.
Time Frame
Change baseline, 10 weeks, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Those showing a high risk of PTSD (TSQ ≥6 or TSQ ≥4 with clinical criteria) will be further evaluated to determine whether they meet the inclusion criteria. Participants must: Be between the ages of 18 and 65 fluent enough in Spanish language; 2. Exclusion Criteria: Present severe active suicidal ideation, or have made a self-injurious attempt during the last month. Present a diagnosis of substance dependence, intellectual disability or severe cognitive dysfunction. Participants with a score greater than or equal to 26 on the BDI-II, the inclusion of the person in the study will be assessed by clinical criteria. Having received EMDR treatment in the last 6 months. Also excluded from the program are those people who cannot guarantee continuity in the therapeutic process.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Valiente
Phone
+34913943135
Email
mcvalien@ucm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Cerezo
Email
ecerez01@ucm.es
Facility Information:
Facility Name
Carmen Valiente
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Valiente, P.h.D
First Name & Middle Initial & Last Name & Degree
Regina Espinosa, P.h.D
First Name & Middle Initial & Last Name & Degree
Belen Lozano

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Learn more about this trial

The Effect of Dual Attention in an EMDR Intervention

We'll reach out to this number within 24 hrs